Our scientists utilize the latest instrumentation and methodologies to provide customers with the highest quality of analytical analysis of MDI’s, DPI’s, nebulizers, and nasal drug products. We develop a specific program to meet all requirements necessary including stability storage conditions and determining the relevant experiments needed according to the industry guidances. At the completion of each project, we provide customers with certificate of analysis and stability reports.
- cGMP compliant laboratory, ISO 17025 Accredited and EQFAR certified laboratory through ANVISA
- Registered with FDA (last inspection January 2016 – no 483s)
- DEA license for controlled drug substances (schedule II-V)
- Accredited to ISO/IEC 17025:2005
- Subject matter experts in:
- Analytical chemistry
- Inhalation physical tests
- Spray characterization
- Particle size analysis
We have a proven track record of working with regulatory agencies to ensure a higher product approval rate.
- US (FDA)
- EU (European Medicines Agency) & Australia
- Canada (Health Canada)